Opportunity
Federal Register #2026-21910
FDA priority review voucher notice for Incyte’s ATEBRIOZ
Buyer
Department of Health and Human Services / Food and Drug Administration
Posted
October 28, 2026
Identifier
2026-21910
The FDA issued a rare pediatric disease priority review voucher related to Incyte Corporation’s ATEBRIOZ (zilurgisertib) product application. - Government buyer/agency: U.S. Department of Health and Human Services (HHS), Food and Drug Administration (FDA). - Notice type: Award notice; this is not a procurement solicitation. - OEM: Incyte Corporation manufactures ATEBRIOZ (zilurgisertib) tablets. - Product context: ATEBRIOZ is indicated to reduce the volume of total new heterotopic ossification in adults and pediatric patients aged 12 years and older with fibrodysplasia ossificans progressiva. - Purchase requirements: No products or services are requested, and no quantities, part numbers, or contract requirements are specified.
Description
The FDA announces issuance of a priority review voucher to the sponsor of the rare pediatric disease product application for ATEBRIOZ (zilurgisertib), manufactured by Incyte Corporation. FDA states the product was approved on September 25, 2026, and meets the criteria for a priority review voucher. ATEBRIOZ tablets are indicated to reduce the volume of total new heterotopic ossification in adults and pediatric patients aged 12 years and older with fibrodysplasia ossificans progressiva.